The customer returned a 2-lumen 8 fr x 20 cm cvc kit catheter with the spring wire guide (swg) still inside of the catheter.The catheter appeared used; however, no defects or anomalies were observed.Visual examination of the swg revealed the guide wire is unraveled from the proximal weld.The distal end of the core wire was undamaged and retained its j shape.The guide wire body also had multiple bends and stretched coils.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire.The proximal core wire protruding is rounded and pinched.The distal weld was still intact.Both the proximal and distal welds appeared full and spherical.The broken core wire measured 602mm in length, which met specification; therefore, no pieces appear to be missing.The outside diameter (od) of the guide wire was also found to be within specification.A swg with an od of 0.846mm from lab inventory passed through the returned catheter from the hub to the tip without restriction.This indicates that a swg with an od of 0.790mm would be able to pass through the catheter as well.A manual tug test confirmed the distal weld is intact.Other remarks: a device history review was performed and no manufacturing issues were identified.The instructions-for-use (ifu) for this product states that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement the catheter should be withdrawn 2-3cm relative to the spring-wire guide and another attempt should be made to remove it.If resistance is felt again the spring-wire guide and catheter should be removed simultaneously.Applying undue force may cause the spring-wire guide to break.The reported complaint that the guide wire unraveled while using the catheter was confirmed through visual examination of the returned sample.The returned guide wire was kinked, unraveled, and the core wire was broken adjacent to the proximal weld.A lab inventory swg with an od of 0.846mm advanced through the returned catheter from the hub to the tip without restriction.This indicates that a swg with an od of 0.790 mm would be able to pass through the catheter as well.No manufacturing defects were found during this investigation.Arrow guide wires of this size (0.035") are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, it was determined that operational context caused or contributed to this issue.
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